A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

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A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event [ Time Frame: From baseline up to 4.9 years ]

Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.

Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke

Time to First CV-EAC Adjudicated Event - Sensitivity Analysis [ Time Frame: From Baseline up to 4.9 years ]

Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis

Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis [ Time Frame: From Baseline up to 4.9 years ]

Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis

Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis [ Time Frame: From baseline up to 4.9 years ]

Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses

Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis [ Time Frame: From baseline up to 4.9 years ]

Percentage of patients with any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses

Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date [ Time Frame: From Baseline up to 4.9 years ]

Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).

Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date [ Time Frame: From Baseline up to 4.9 years ]

Percentage of participants with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).

Secondary Outcome Measures
:

The Time to First Occurrence of an Expanded CV Composite Endpoint [ Time Frame: From baseline up to 4.9 years ]

Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.

Percentages of Participants With an Expanded CV Composite Endpoint [ Time Frame: From baseline up to 4.9 years ]

Percentages of participants with the expanded CV composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.

Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction [ Time Frame: From baseline up to 4.9 years ]

Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal Myocardial Infarction

Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction [ Time Frame: From baseline up to 4.9 years ]

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Ages Eligible for Study:

50 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Participants with moderate to severe RA of greater than or equal to (>=6) months duration

History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low High Density Lipoprotein (HDL) cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis

At the time of randomization, will have discontinued infliximab, adalimumab, golimumab, or certolizumab for >= 4 weeks

Exclusion Criteria:

Major surgery (including joint surgery or coronary revascularization) within 8 weeks prior to screening or planned major surgery within 1 year of study start

History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations

Current liver disease as determined by the investigator; a history of asymptomatic elevations in liver function tests (LFTs) is not considered an exclusion

Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds

Any major episode of infection requiring hospitalization or treatment with IV antibiotics within four weeks of screening or oral antibiotics within two weeks prior to screening visit

Latent TB diagnosed during screening that has not been appropriately treated

Primary or secondary immunodeficiency (history of or currently active)

Moderate to severe heart failure

Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematologic malignancies and solid tumors, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years

Breast feeding mothers

History of alcohol, drug or chemical abuse within the 6 months prior to screening